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Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction

RecruitingNAAges 18 Years - anyAllUniversity of Pittsburgh
NCT07694726 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

\* The goal of this clinical trial is to learn if facial vein reconstruction after neck dissection works to reduce rates of lymphedema in adults getting surgical treatment for head and neck cancer. This is a trial which aims to improve the rate of lymphedema for patients undergoing treatment for head and neck cancer. Our aim is to re-establish venous flow across the facial vein to improve lymphatic drainage after neck dissection. * The investigators will also evaluate lymphatic flow before and after facial vein reconstruction to determine if there is evidence of lymphedema. * The main questions this study aims to answer are: 1. Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients? 2. Determine if there are changes in lymphatic flow before and after facial vein reconstruction? After the study is completed, the investigators

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📋 Eligibility rules (as published)
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Ability to comply with the study protocol, including follow up visits and additional requirements for data collection * Ability to provide informed consent * Patients requiring unilateral or bilateral neck dissection. Patients must undergo at least three level neck dissection which must include level 1B * Patients will undergo radiotherapy +/-chemotherapy after surgery for HNC. Patients will be required to have adjuvant therapy after surgery to have similar risk of development of lymphedema. * No history of allergy to indocyanine green. Exclusion Criteria: * Shellfish Allergy * Contraindication to surgery under general anesthesia * Prior head and neck surgery, radiation, or chemotherapy for HNC * Patients requiring sacrifice of the internal jugular vein or resection of neck skin for oncologic care * Anticipated partial or total laryngectomy * Pregnancy or lactation
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What it tests

  • Facial Vein Reconstruction
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Where

1 site
UPMC Presbyterian Hospital and UPMC Shadyside Hospital
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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